🇪🇺 Prevenar 13 in European Union

EMA authorised Prevenar 13 on 9 December 2009

Marketing authorisation

EMA — authorised 9 December 2009

  • Application: EMEA/H/C/001104
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Prevenar 13
  • Indication: Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, und
  • Status: approved

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Prevenar 13 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Prevenar 13 approved in European Union?

Yes. EMA authorised it on 9 December 2009.

Who is the marketing authorisation holder for Prevenar 13 in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.